112 ACCELERATED TITRATION DESIGNS 34. Y. Matsumura, T. Hamaguchi, T. Ura, K Muro, Y. Yamada, Y. Shimada, K Shirao, T. Okusaka, H. Ueno, M. Ikeda and N. Watanabe (2004) Phase I clinical trial and 91(10), phara- cokinetic evaluation ofNK911, a micelle-encapsulated doxorubicin. Br. J. Cancer, 1775-81. 35. MJ. de Jonge, J. Verweij, A van der Gaast, O. Valota, O. Mora, AS. Planting, M.A Mantel, S.V. Bosch, MJ. Lechuga, F. Fiorentini, D. Hess and C. Sessa (2002) Phase I and pharacokinetic studies of PNU-159548, a novel alycycline, administered intravenously to patients with advanced solid tumours. Eur. J. Cancer, 38(18), 2407-15. 36. AC. Lockhar, M. Howard, KR. Hande, BJ. Roth, J.D. Berlin, F. Vreeland, A Campbell, E. Fontana, F. Fiorentini, C. Fowst, V.A. Paty, O. Lanord and M.L. Rothenberg (2004) A phase I dose-escalation and pharacokinetic study of brostallicin (PNU-166196A), a novel DNA minor groove binder, in adult patients with advanced solid tumors. CUn. Cancer Res., 10(2),468-75. 37. AJ. Ten Tije, 1. Verweij, A Spareboom, A Van Der Gaast, C. Fowst, F. Fiorentini, J. Tursi, A Antonellni, M. Mantel, C.M. Harman, G. Stoter, A.S. Planting and MJ. De Jonge (2003) Phase I and pharacokinetic study of brostallicin (PNU-166196), a new DNA minor-groove binder, administered intravenously every 3 weeks to adult patients with metastatic cancer. CUn. Cancer Res., 9(8), 2957-6. 38. J. Dupont, B. Bienvenu, C. Aghajanian, S. Pezzull, P. Sabbatini, P. Vongphrachan, C. Chang, C. Perkell, K Ng, S. Passe, L. Breimer, J. Zhi, M. DeMaro, D. Spriggs and S.L. Soignet (2004) Phase I and pharacokinetic study of the novel oral cell-cycle inhibitor Ro 31-7453 in patients with advanced solid tumors. J. CUn. Oncology, 22(16), 3366- 74. 39. R. Salazar, D. Bissett, C. Twelves, L. Breimer, M. DeMaro, S. Campbell, J. Zhi, S. Ritland and J. Cassidy (2004) A phase I clinical and pharacokinetic study of Ro 31-7453 given as a 7- or 14-day oral twice daily schedule every 4 weeks in patients with solid tumors. Clin. Cancer Res., 10(13),4374-82. 40. S. Wadler, D. Makower, C. Clairmont, P. Lambert, K Fehn and M. Sznol (2004) Phase I and pharacokinetic study of the ribonucleotide reductase inhbitor, 3-aminopyridine- 2-carboxaldehyde thiosemicarbazone, administered by 96-hour intravenous continuous infusion. J. CUn. Oncology, 22(9), 1553-63. 41. 1. Murren, M. Modiano, C. Clairmont, P. Lambert, N. Savaraj, T. Doyle and M. Sznol (2003) Phase I and pharacokinetic study of trapine, a potent ribonucleotide reductase inhibitor, administered daily for five days in patients with advanced solid tumors. CUn. Cancer Res., 9(11), 4092-100. 42. P.H. Jones, R.D. Burnett, i. Fainar, P. Nadolny, P. Walker, Z. Yu, D. Tang-Liu, T.S. Ganesan, D.C. Talbot, AL. Hars and GJ. Rustin (2003) A phase 1 study of tazarotene in adults with advanced cancer. Br. J. Cancer, 89(5), 808-15. 43. S.E. AI-Batran, A Atmaca, F. Bert, D. Jäger, C. Frisch, A. Neumann, J. Ort, A Knuth and E. Jäger (2004) Dose escalation study for defining the maximum tolerated dose of continuous oral trofosfamide in pretreated patients with metastatic lung cancer. Onkologie, 27(6), 534-8. 44. E.C. Dees, S.D. Baker, S. O'Reily, M.A Rudek, S.B. Davidson, C. Ayleswort, K Elza- Brown, M.A Carducci and R.C. Donehower (2004) A phase I and phanacokinetic study of short infusions ofUCN-Ol in patients with refractory solid tumors. Clin. Cancer Res., 11(2 Pt 1), 664-71. -
T ¡ ¡ ¡ i I t I ¡ l ¡ t i I t ¡ r l I , r ~ r l i i I r t r Fe l a I l i ~ ~ ~ ,f iIL ACCELERATED TITRATION DESIGNS 45. B.C. Goh, M.J. Ratain, D. Bertucci, R Smith, S. Mani, N.J. Vogelzang, R.L. Schilsky, M. Hutchison, M. Smith, S. Averbuch and E. Douglass (2001) Phase I study of ZD9331 on short daily intravenous bolus infusion for 5 days every 3 weeks with fixed dosing recommendations. J. Clin. Oncology, 19(5), 1476-84. 46. E. Horstmann, M.S. McCabe, L. Grochow, S. Yamamoto, L. Rubinstein, T. Budd, D. Shoemaker, E.J. Emanuel and C. Grady (2005) Risks and benefits of phase 1 oncology trals, 1991 through 2002. N. Engl. J. Medicine, 352(9),895-904. 47. R Kurzrock and RS. Benjamin (2005) Risks and benefits of phase I oncology trals, revisited. N. Engl. 1. Medicine, 352(9), 930-2. 113
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